Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit… — Class III medical device recall Z-2650-2017
Terminated recall by Medtest Holdings, Inc., reported 2017-07-05, distributed nationwide. Linear performance information in product insert does not match that listed in the approved premarket notifica
| Recall number | Z-2650-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtest Holdings, Inc., Canton, MI, United States |
| Recall initiated | 2011-10-19 |
| Classified | 2017-06-29 |
| Reported by FDA | 2017-07-05 |
| Terminated | 2017-07-24 |
| Distributed | Nationwide (US) |
| Quantity | 319.922 l |
| Lot numbers | 020902, 029902, 029903, 113204, 129403, 209001 |
| Model numbers | C7522, HC422, HC722, HC922 |
| Expiration dates | 2012-07 |
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 for recall
Linear performance information in product insert does not match that listed in the approved premarket notification
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2650-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.