Recall Z-2050-2020 ยท JJW Urinalysis Controls (Assayed And Unassayed)
Cardinal Health Inc.
Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere Professional Cup Urine Drug Controls are compatible with all quantitative and qualitative drug detection procedures which are sufficiently sensitive to detect the control constituents.
| Date | Apr 20, 2020 |
| Status | Terminated |
| Reason | Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products may result in misdiagnosis of the patient. |
| Root cause | Storage |
| Action | On April 20, 2020, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were informed that the product had been incorrectly stored and that there was a potential for misdiagnosis. Action Required: 1. CHECK all storage and usage locations to confirm whether you have any units of the affected product codes and lot numbers containing the labeling outlined in the letter. 2. SEGREGATE and QUARANTINE all on-hand affected product. 3. PLEASE RETURN the letter's acknowledgment form via facsimile (847-689-9101 or 614-652-9648) or email (GMB-FieldCorrectiveAction@ca |
| Distribution | US Nationwide distribution NC, KS, and AL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.