FDA Device recall Z-2650-2017
Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution
- FDA Device
- Class III
- terminated
- Published 2017-07-05
On 2017-07-05 the FDA classified a Class III recall of Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution by Medtest Holdings, citing linear performance information in product insert does not match that listed in the approved premarket notification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2650-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2011-10-19 |
| Published | 2017-07-05 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtest Holdings |
| Distribution | US |
Product
Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the kinetic quantitative determination of creatine kinase activity in serum.
Reason
Linear performance information in product insert does not match that listed in the approved premarket notification
Identifiers
| code_info | Models: C7522, HC422, HC722, HC922. Lot#'s: 020902; 029902 R1; 029902 R2; 029903; 113204; 129403; 209001. Exp dates 7/2012 to 9/2013. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2650-2017%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.