Z-1608-2023Class II

Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL

Name: Z-1608-2023 Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL
Creator: Beckman Coulter Inc.
Published: 2023-04-05
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2023-04-05 / Open, Classified / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL on 2023-04-05. FDA classified it as Class II and gives the reason as "There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1608-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-04-05
Posted: 2023-05-18
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL
Product code: KHS Enzymatic, Carbon-Dioxide
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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: On April 5, 2023, Beckman Coulter (BEC) issued a "URGENT MEDICAL DEVICE RECALL" Notification via mail and/or E-Mail. In addition, to informing consignees about the recalled product, BEC asked consignees to take the following actions: 1. Safely dispose of the Bicarbonate lot numbers that are specifically described in Table A. 2. If replacement or re-imbursement of the above lots is required, customers are directed to contact their local Beckman Coulter representative for replacement and re-imbursement. 3. Customers are advised to implement the adjusted Calibration OD range using the instructions within the customer letter to avoid generation of elevated results for all other Bicarbonate lots. 4. Retrospective review of patient data is not required due to the remote possibility of generating falsely elevated, clinically impactful results which could cause a change in treatment. Please share the content of this letter with your laboratory and/or medical director regarding the need to review previous patient test results. 4. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forward any of the affected products(s) listed above to another laboratory, please provide them a copy of the letter. 5. Please respond within 10 days in one of the following ways: - Electronically, you received this communication via email. - Manually, complete and return the enclosed Response Form. 6. If you have any questions, please call 1-800-854-3633
Quantity in commerce: 48,633 units in total
Distribution: 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,
Product codes and lots: All Lots: UDI-GI: 15099590060206

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1608-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1606-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-24	2023-05-18
Z-1607-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-24	2023-05-18
Z-1608-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-24	2023-05-18

Product code KHS

K131546Class IIAu Bicarbonate ReagentBeckman Coulter Ireland, Inc. / cleared 2013-10-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)