Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube… — Class III medical device recall Z-2764-2015
Terminated recall by Pointe Scientific, Inc., reported 2015-09-23, distributed in CA, CT, FL, MI, PR, TX. Crystals may be observed in the R1 reagent. Crystals may be a result of the reagent being frozen during transp
| Recall number | Z-2764-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pointe Scientific, Inc., Canton, MI, United States |
| Recall initiated | 2015-03-13 |
| Classified | 2015-09-16 |
| Reported by FDA | 2015-09-23 |
| Terminated | 2015-10-29 |
| Distributed | CA, CT, FL, MI, PR, TX |
| Countries outside the US | CA |
| Lot numbers | 430402 |
| Model numbers | 12-H7545-162, H7545-1000, H7545-R1, HDL600 |
Product
Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bottle H7545-1000 kit includes 1x750 ml of R1 and 1x250 ml of R2 12-H7545-162 kit includes 3x40 ml of R1 and 3x14 ml of R2 HDL600 kit includes 3x40 ml of R1 and 3x14 ml of R2 Kits: HDPE plastic bottle, PP plastic caps. Bulk: PE plastic cube containers, PP plastic caps. Quantitative determination of high density lipoprotein cholesterol in human serum or plasma. In vitro diagnostic use only.
Reason for recall
Crystals may be observed in the R1 reagent. Crystals may be a result of the reagent being frozen during transport. The crystals do not impact product performance.
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-2764-2015. 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.