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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92071

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

Open FDA event record

Event summary

Timeline bucket
April 05, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Beckman Coulter 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

3 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 3

Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL

Z-1606-2023
Recall number
Z-1606-2023
Initiated
April 05, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Beckman Coulter Inc.
Quantity
48,633 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures.

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

There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures.

Code information

All Lots: UDI-GI: 15099590020187

Distribution pattern

Worldwide Distribution: US (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Guam, & Puerto Rico and OUS (foreign) countries of: Brazil ,Canada, Mexico, Panama, Taiwan,

device · product 2 of 3

Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mL

Z-1607-2023
Recall number
Z-1607-2023
Initiated
April 05, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Beckman Coulter Inc.
Quantity
48,633 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures.

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

There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures.

Code information

All Lots: UDI-GI: 15099590010348

Distribution pattern

Worldwide Distribution: US (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Guam, & Puerto Rico and OUS (foreign) countries of: Brazil ,Canada, Mexico, Panama, Taiwan,

device · product 3 of 3

Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL

Z-1608-2023
Recall number
Z-1608-2023
Initiated
April 05, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Beckman Coulter Inc.
Quantity
48,633 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures.

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

There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures.

Code information

All Lots: UDI-GI: 15099590060206

Distribution pattern

Worldwide Distribution: US (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Guam, & Puerto Rico and OUS (foreign) countries of: Brazil ,Canada, Mexico, Panama, Taiwan,