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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85203

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

Open FDA event record

Event summary

Timeline bucket
March 16, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Life Technologies Corporation

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

4 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 4

Oncomine Dx Target Test DNA Control-IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32442.

Z-1704-2020
Recall number
Z-1704-2020
Initiated
March 16, 2020
Classification
Class II
Status
Terminated
Quantity
66 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Extended Expiration Date prior to clearance

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Incorrect or no expiration date

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Extended Expiration Date prior to clearance

Code information

Lot Codes: S119_2174741 S119_2161574 P119_2149301 N119_2078113 S218_2069394 V118_1991153 T118_1990945 S217_2008383 S118_1988602 P118_1996941 S117_1988305 UDI: (01)10190302006095

Distribution pattern

US Nationwide distribution.

device · product 2 of 4

Oncomine Dx Target Test RNA Control- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32443

Z-1705-2020
Recall number
Z-1705-2020
Initiated
March 16, 2020
Classification
Class II
Status
Terminated
Quantity
66 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Extended Expiration Date prior to clearance

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Incorrect or no expiration date

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Extended Expiration Date prior to clearance

Code information

Lot Codes: S119_2174739 S119_2108428 P119_2149305 N119_2078114 S218_2069395 V118_1991154 T118_1990946 S118_1988603 P118_1996940 S117_1988306 UDI: (01)10190302006064

Distribution pattern

US Nationwide distribution.

device · product 3 of 4

Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32441

Z-1706-2020
Recall number
Z-1706-2020
Initiated
March 16, 2020
Classification
Class II
Status
Terminated
Quantity
35 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Extended Expiration Date prior to clearance

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Incorrect or no expiration date

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Extended Expiration Date prior to clearance

Code information

Lot Codes: S119_2174743 S119_2188760 S119_2165333 P119_2149298 S217_04001 1705002 UDI: (01)10190302015103

Distribution pattern

US Nationwide distribution.

device · product 4 of 4

Ion Torrent Dx No Template Control Kit- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens Catalog Number: A32444

Z-1707-2020
Recall number
Z-1707-2020
Initiated
March 16, 2020
Classification
Class II
Status
Terminated
Quantity
79 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Extended Expiration Date prior to clearance

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Incorrect or no expiration date

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Extended Expiration Date prior to clearance

Code information

Lot Codes: S119_2174740* S119_2108429* P119_2149308 N119_2078115 S218_2069396 V118_1991155 T118_1990947 S217_2008385 S118_1988604 P118_1996942 N118_1974439 S117_1988308 * Mislabeled with a 24-month expiration date. However, the approved shelf life of the vials is also 9 months. Please note, the kit level labelling for the two impacted lots of Ion Torrent Dx No Template Control kit shows a 12-month expiration date, which is also incorrect UDI: (01)10190302006156

Distribution pattern

US Nationwide distribution.