BD Vacutainer Urine Collection Cups, Cat. No. 364941
FDA Recall Z-0491-2019 · Posted None
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Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeJTW
Date Initiated2018-08-30
Date Terminated2020-10-21
Product QuantityTotal: 29,982,150 BD cups (US); 97,800,900 BD cups (OUS)
Reason for Recall
BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) counts when used with the Sysmex UF Series Analyzers. BD recommends following Good Clinical Practice (GCP) by using microscopy to confirm an elevated RBC Count in a Urine sample as per CLSI GP16-3A. 29(4) and CAP Checklist on Urinalysis. Product will continue to ship to not impact critical patient care.
Firm Action
On August 30, 2018, BD notified Sysmex via an emailed Urgent Medical Device Product Safety Alert letter. Sysmex was informed that BD had confirmed the product issue with BD Vacutainer Urine Collection Cups were used with Sysmex UF Series Analyzers.
Sysmex was instructed to take the following actions:
- Notify Sysmex customers of the potential for elevation of RBC counts
- Complete the customer Resopnse form and email it to BD at [email protected] to confirm receipt of the Safety Alert.
Product will continue to ship so as to not impact critical patient care.
BD recommends following Good Clinical Practice (GCP) by performing microscopy to confirm an elevated RBC Count in a urine sample as per CLSI GP16-3A.29(4) and CAP Checklist on Urinalysis.
Root Cause
Under Investigation by firm
Distribution Pattern
Illinois
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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