Recall Z-1846-2025 ยท CGL Electrode, Ion Based, Enzymatic, Creatinine
Mckesson Medical-Surgical Inc. Corporate Office
ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE.
| Date | May 27, 2025 (initiated Apr 24, 2025) |
| Status | Open, Classified |
| Reason | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result. |
| Root cause | Storage |
| Action | An URGENT PRODUCT RECALL notification dated 4/21/25 was mailed to consignees. The notification instructs consignees to immediately examine their inventory and quarantine all product identified as subject to this recall action. Consignees are asked to return the completed response form to MMSQARecalls@McKesson.com and to destroy any quarantined devices. Questions about this recall can be directed to 1-800-688-8840 from 8:00 am to 5:00 pm Monday through Friday. If product has been further distributed, consignees are asked to forward the provided recall notice to those customers. |
| Quantity | 25 units |
| Distribution | US Nationwide distribution in the states of AL, AR, IL, KS, MT, NC, NJ, OR, SC, TN & WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053110 | Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbot I-Stat Corporation, Jan 13, 2006 |