Pointe Scientific autoHDL Reagent Recalled Due to Potential Crystals
Pointe Scientific is recalling autoHDL Reagent H7545 because crystals may be present in the R1 reagent, potentially resulting from freezing during transport.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, and the source text explicitly states that the crystals do not impact product performance, fitting the criteria for cosmetic or packaging-only issues.
Plain-English summary
Pointe Scientific, Inc. is recalling the autoHDL Reagent H7545, including specific bulk and kit configurations. The recall is due to the potential presence of crystals in the R1 reagent. The source text indicates that these crystals may be a result of the reagent being frozen during transport.
The affected products include the H7545-R1 in bulk cube containers or HDPE plastic bottles, the H7545-1000 kit, the 12-H7545-162 kit, and the HDL600 kit. The specific lot number is 430402. The products were distributed worldwide, including in the United States (Michigan, Florida, California, Texas, Connecticut, Puerto Rico) and Canada.
The source text explicitly states that the crystals do not impact product performance. This recall is classified as Class III by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- 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:
- Manufacturer
- Pointe Scientific, Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Catalog numbers: H7545-R1
- 12-H7545-162
- H7545-1000
- HDL600 Lot number: 430402
Distribution
Related recalls
Same manufacturer · Pointe Scientific, Inc.
See all →- LowPointe Scientific Creatinine Reagent Recall Due to Labeling Error
FDA (Devices) · 2015-09-23
- ModeratePointe Scientific Recalls G6PD Controls Due to Reduced Stability
FDA (Devices) · 2015-09-09
Same hazard · product defect
See all →- SevereShilpa Medicare Recalls Discolored Pemetrexed Injection Vials
FDA (Drugs) · 2026-08-26
- ModerateShilpa Medicare Recalls Discolored PEMRYDI RTU Injection Vials
FDA (Drugs) · 2026-08-26
- ModerateMedline Sterile Water and Saline Bottles Recalled for Leaking Peel-Foil Seals
FDA (Devices) · 2025-05-07
- HighCELL-DYN Ruby hematology analyzer system expiration date validation
FDA (Devices) · 2025-04-30
- HighMedline Procedure Kits with Defective Plastic Syringes Recalled for Safety
FDA (Devices) · 2025-04-02