Pointe Scientific CRP — Class III medical device recall Z-2631-2017
Terminated recall by Medtest Holdings, Inc., reported 2017-07-05, distributed in CA, FL, HI, MD, MS, NJ, NV, OK…. Individual vials of calibrator and standard were mislabeled; specifically the units on the vial labels are inc
| Recall number | Z-2631-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtest Holdings, Inc., Canton, MI, United States |
| Recall initiated | 2009-07-21 |
| Classified | 2017-06-26 |
| Reported by FDA | 2017-07-05 |
| Terminated | 2017-07-24 |
| Distributed | CA, FL, HI, MD, MS, NJ, NV, OK, PA |
| Countries outside the US | CL |
| Quantity | 323 vials |
| Reason classes | labeling |
| Lot numbers | 717303-131, 902701-111, 902701-131, C7568-CTL, C7568-STD |
| Model numbers | 717303-131, 902701-111, 902701-131, C7568-CTL, C7568-STD |
| Expiration dates | 2009-06, 2011-01 |
Product
Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) Wide Range Standard Set 5 Levels of 1 x 2 ml ready to use calibrator or standard The Pointe Scientific CRP (HS) Wide Range Multi-Calibrator Set is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only. The Pointe Scientific CRP (HS) Wide Range Multi-Standard Set Is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only
Reason for recall
Individual vials of calibrator and standard were mislabeled; specifically the units on the vial labels are incorrectly listed as mg/dl when the correct unit is mg/L.
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-2631-2017. 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.