Pointe Scientific Creatinine Reagent Catalog number C7539-150 in… — Class III medical device recall Z-2773-2015
Terminated recall by Pointe Scientific, Inc., reported 2015-09-23, distributed nationwide. Creatinine kit C7539-150 contains Creatinine reagent R1 that is labeled as Creatinine reagent R2 (30ml) and re
| Recall number | Z-2773-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pointe Scientific, Inc., Canton, MI, United States |
| Recall initiated | 2014-12-12 |
| Classified | 2015-09-16 |
| Reported by FDA | 2015-09-23 |
| Terminated | 2015-10-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | BO, GR, GY, KE, MX, PH, SG |
| Quantity | 93 kits |
| Reason classes | labeling, specification failure |
| Lot numbers | 2016-03, 279, 406201 |
| Model numbers | C7539-150 |
Product
Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-150 kit includes one R1 and one R2 bottle. R1: HDPE plastic bottle. 120 ml fill. R2: HDPE plastic bottle. 90 ml fill.
Reason for recall
Creatinine kit C7539-150 contains Creatinine reagent R1 that is labeled as Creatinine reagent R2 (30ml) and reagent R2 vial is labeled as R1 (120ml). With manual procedure, no result will be reported as the control will be out of specifications.
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-2773-2015. 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.