FDA Device recall Z-1076-2019
Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341
- FDA Device
- Class II
- terminated
- Published 2019-04-10
On 2019-04-10 the FDA classified a Class II recall of Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341 by Abbott Laboratories, citing the product has a stability issue which may lead to an error code indicating "Unable to calculate result, reaction check failure" and/or Quality Control results out of range low.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1076-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-18 |
| Published | 2019-04-10 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Abbott Laboratories |
| Distribution | US |
Product
Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.
Reason
The product has a stability issue which may lead to an error code indicating "Unable to calculate result, reaction check failure" and/or Quality Control results out of range low.
Identifiers
| code_info | Lot number 99633UN18, exp. 02JAN19, UDI (01)00380740101176(17)190102(10)99633UN18. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1076-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.