APLS IgM Diagnostic Reagent Packs Recalled Due to Incorrect Conjugate
Bio-Rad Laboratories is recalling 932 BioPlex 2200 APLS IgM Reagent Packs (Lot 301538) nationwide because they were packaged with incorrect conjugate. This could result in false-positive and false-negative test results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall involving diagnostic reagent packaging error that could result in false test results. No illnesses, injuries, or hospitalizations have been reported. This constitutes a risk-of-harm product where analytical error poses potential for patient impact, but no harm has yet been documented.
Plain-English summary
Bio-Rad Laboratories, Inc. is recalling 932 BioPlex 2200 APLS IgM Reagent Packs (REF 665-2050, Lot Code 301538) due to a packaging error.
The recalled packs were packaged with an incorrect conjugate, which could produce false-positive and false-negative results when used for APLS IgM testing.
The affected packs were distributed nationwide throughout the United States and Puerto Rico, including Alabama, Arizona, Arkansas, California, Connecticut, Florida, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, South Carolina, Tennessee, Texas, Utah, and Vermont.
The recalled product
- Product
- BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
- Manufacturer
- Bio-Rad Laboratories, Inc.
- Affected units
- 932
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 (2)
- Lot Code: 301538
- UDI-DI: (00)847865000666
Distribution
Related recalls
Same manufacturer · Bio-Rad Laboratories, Inc.
See all →- HighToxoplasma IgM assay kits recalled over risk of false positive results
FDA (Devices) · 2025-09-10
- HighBioPlex 2200 Anti-CCP Reagent Pack Recalled for Reduced Diagnostic Specificity
FDA (Devices) · 2023-04-19
- HighBioPlex 2200 Anti-CCP Reagent Kit recalled due to reduced test specificity
FDA (Devices) · 2023-04-19
- HighCMV IgM EIA Diagnostic Test Recalled for Increased False Positives
FDA (Devices) · 2022-12-07
- HighBio-Rad Sickle Cell Testing Software CD-ROM Defect Overwrites Custom Settings
FDA (Devices) · 2022-06-08
Same hazard · packaging error
See all →- ModerateTerumo Glidesheath Slender A-Kit Recalled for Incorrect Guidewire Packaging
FDA (Devices) · 2026-08-19
- LowRio II Nasal Pillows Interface Packaging and Labeling Discrepancy Recall
FDA (Devices) · 2026-07-22
- ModerateEMPOWR 3D KNEE insertion instruments recalled for incorrect product size packaging
FDA (Devices) · 2026-07-15
- ModerateArtegraft vascular graft recalled over incorrect lot outer packaging labeling
FDA (Devices) · 2026-03-25
- ModerateBD syringe batch may contain Luer Slip instead of Luer Lok
FDA (Devices) · 2026-03-18