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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76915

6 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 21, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Siemens Healthcare Diagnostics, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 6

Dimension Troponin 1 (TNI) Flex reagent cartridge

Z-2606-2017
Recall number
Z-2606-2017
Initiated
March 21, 2017
Classification
Class II
Status
Terminated
Quantity
70,428 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere.

Code information

Device Listing Number # D056469 Lot # EB7091, EC7104, EA7125, ED7193, EA7161, EB7173, EC7229, ED7236 EA7250, ED7271, EB7315, EB7342 "

Distribution pattern

Product was distributed throughout the United States and Canada, United Arab Emirates, Argentina, Austria,Australia,Bangladesh,Belgium,Brazil,Canada Switzerland,China,Columbia,Czech Republic,Germany,Denmark,Algeria Egypt,Spain,Finland,France,Great Britain,Greece,Croatia,Indonesia,Ireland India,Italy,Japan,Canary Islands,Republic of Korea,Kuwait,Lebanon,Latvia Macedonia,Netherlands,Norway,New Zealand,Philippines,Poland,Portugal Qatar,Saudi Arabia,Slovenia,Slovakia,Turkey,Taiwan,South Africa

device · product 2 of 6

Dimension Vista Digoxin (DIGXN) Flex reagent cartridge

Z-2607-2017
Recall number
Z-2607-2017
Initiated
March 21, 2017
Classification
Class II
Status
Terminated
Quantity
13,143 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere.

Code information

Device Listing Number # D098364 Lot # 16103BD, 16195BB, 16230BA, 16259BD, 16320BD, 16363BA

Distribution pattern

Product was distributed throughout the United States and Canada, United Arab Emirates, Argentina, Austria,Australia,Bangladesh,Belgium,Brazil,Canada Switzerland,China,Columbia,Czech Republic,Germany,Denmark,Algeria Egypt,Spain,Finland,France,Great Britain,Greece,Croatia,Indonesia,Ireland India,Italy,Japan,Canary Islands,Republic of Korea,Kuwait,Lebanon,Latvia Macedonia,Netherlands,Norway,New Zealand,Philippines,Poland,Portugal Qatar,Saudi Arabia,Slovenia,Slovakia,Turkey,Taiwan,South Africa

device · product 3 of 6

Dimension Vista Estradiol (E2) Flex reagent cartridge

Z-2608-2017
Recall number
Z-2608-2017
Initiated
March 21, 2017
Classification
Class II
Status
Terminated
Quantity
1,697 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere.

Code information

Device Listing Number # D121541 Lot # 16148AA, 16190BA, 16201BA, 16228BC, 16256BA, 16277BB 16298AB, 16343BE,17005BC

Distribution pattern

Product was distributed throughout the United States and Canada, United Arab Emirates, Argentina, Austria,Australia,Bangladesh,Belgium,Brazil,Canada Switzerland,China,Columbia,Czech Republic,Germany,Denmark,Algeria Egypt,Spain,Finland,France,Great Britain,Greece,Croatia,Indonesia,Ireland India,Italy,Japan,Canary Islands,Republic of Korea,Kuwait,Lebanon,Latvia Macedonia,Netherlands,Norway,New Zealand,Philippines,Poland,Portugal Qatar,Saudi Arabia,Slovenia,Slovakia,Turkey,Taiwan,South Africa

device · product 4 of 6

Dimension Vista Ferritin (FERR) Flex reagent cartridge

Z-2609-2017
Recall number
Z-2609-2017
Initiated
March 21, 2017
Classification
Class II
Status
Terminated
Quantity
29,266 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere.

Code information

Device Listing Number # D011479 Lot # 16102BF, 16144BB,16196BD,16201BF,16214BF,16236BA 16252AB,16277BC,16284AB,17012BC,17012BD,17034BA,16112BB 16148BA,16165BE,16195BA,16223AD,16259BC,16285BE,16312BD 16334BE,17004BA,17038BC

Distribution pattern

Product was distributed throughout the United States and Canada, United Arab Emirates, Argentina, Austria,Australia,Bangladesh,Belgium,Brazil,Canada Switzerland,China,Columbia,Czech Republic,Germany,Denmark,Algeria Egypt,Spain,Finland,France,Great Britain,Greece,Croatia,Indonesia,Ireland India,Italy,Japan,Canary Islands,Republic of Korea,Kuwait,Lebanon,Latvia Macedonia,Netherlands,Norway,New Zealand,Philippines,Poland,Portugal Qatar,Saudi Arabia,Slovenia,Slovakia,Turkey,Taiwan,South Africa

device · product 5 of 6

Dimension Vista Prolactin (PRL) Flex reagent cartridge

Z-2610-2017
Recall number
Z-2610-2017
Initiated
March 21, 2017
Classification
Class II
Status
Terminated
Quantity
3,443 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere.

Code information

Device Listing Number # A836016 Lot # 16112BB, 16148BA,16165BE,16195BA,16223AD,16259BC 16285BE,16312BD,16334BE,17004BA,17038BC

Distribution pattern

Product was distributed throughout the United States and Canada, United Arab Emirates, Argentina, Austria,Australia,Bangladesh,Belgium,Brazil,Canada Switzerland,China,Columbia,Czech Republic,Germany,Denmark,Algeria Egypt,Spain,Finland,France,Great Britain,Greece,Croatia,Indonesia,Ireland India,Italy,Japan,Canary Islands,Republic of Korea,Kuwait,Lebanon,Latvia Macedonia,Netherlands,Norway,New Zealand,Philippines,Poland,Portugal Qatar,Saudi Arabia,Slovenia,Slovakia,Turkey,Taiwan,South Africa

device · product 6 of 6

Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge

Z-2611-2017
Recall number
Z-2611-2017
Initiated
March 21, 2017
Classification
Class II
Status
Terminated
Quantity
19, 927.00

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere.

Code information

Device Listing Number # D230089 Lot # 16118BD, 16159BA,16193BC,.16193BD,16208AA,16251BA 16277BD,16322BB,17005BB,17023AC

Distribution pattern

Product was distributed throughout the United States and Canada, United Arab Emirates, Argentina, Austria,Australia,Bangladesh,Belgium,Brazil,Canada Switzerland,China,Columbia,Czech Republic,Germany,Denmark,Algeria Egypt,Spain,Finland,France,Great Britain,Greece,Croatia,Indonesia,Ireland India,Italy,Japan,Canary Islands,Republic of Korea,Kuwait,Lebanon,Latvia Macedonia,Netherlands,Norway,New Zealand,Philippines,Poland,Portugal Qatar,Saudi Arabia,Slovenia,Slovakia,Turkey,Taiwan,South Africa