FDA Device recall Z-1075-2019
Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21
- 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 7D63-21 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-1075-2019 |
| 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 7D63-21.
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 87697UN18, exp. 22OCT18; UDI (01)00380740012878 (17)181022(10)87697UN18; Lot number 99632UN18, exp. 12NO…Lot number 87697UN18, exp. 22OCT18; UDI (01)00380740012878 (17)181022(10)87697UN18; Lot number 99632UN18, exp. 12NOV18, UDI (01)00380740012878 (17)181112(10)99632UN18; and Lot 24358UN18, exp. 05DEC18, UDI (01)00380740012878 (17)181205(10)24358UN18. |
|---|
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-1075-2019%22
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