Summary
The FDA issued a Class II for Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL by Beckman Coulter Inc.. Reason: There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control fail.
Details
Source
Device Recall
External ID
Z-1608-2023
Action Date
2023-05-24
Status
Ongoing
Category
device
Product Description
Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL
Lot/Code Info: All Lots: UDI-GI: 15099590060206
Quantity Affected: 48,633 units in total
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.
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,
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-05
Company
Brea, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 147 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Beckman Coulter Inc. has 158 FDA actions in our database, including 111 recalls and 47 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Beckman Coulter Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Beckman Coulter Inc. have FDA actions?
Beckman Coulter Inc. has 158 FDA actions in our database, including 111 recalls and 47 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1608-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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