Recall Z-1312-2024 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Mckesson Medical-Surgical Inc. Corporate Office
Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive Level / Negative Level 2 X 4 mL
| Date | Mar 19, 2024 (initiated Jan 9, 2024) |
| Status | Open, Classified |
| Reason | Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result. |
| Root cause | Storage |
| Action | McKesson notified customers by phone January 9, 2024 with a follow-up call January 17, 2024 instructing customers of three scenarios based upon the products they received and the investigation in conjunction with relevant manufacturer. The firm also sent Urgent Product Recall Notifications via email on February 8, 2024 instructing customers to immediately examine inventory and quarantine all affected devices, complete and return the provided response form to MMSQRCProductReviews@Mckesson.com, and notify customers who you have further distributed recalled devices to of this recall and to segreg |
| Quantity | 3 units |
| Distribution | US Nationwide distribution in the states of AZ, PA and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050328 | PREGNANCY-SKREEN Biochemical Diagnostic, Inc., Mar 29, 2005 |