Recall Z-0082-2022— Bio-Rad Laboratories, Inc.
Class II · Terminated
Class II FDA medical device recall by Bio-Rad Laboratories, Inc., initiated 2019-11-01, terminated 2023-09-27. It names 2 FDA 510(k) clearances: K113610, K041658. Product: BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent Packs/ANA Kits, REF: 665-1150; and ANA Screen Calibrator Sets, REF: 663-1101. Reason: A new lot of ANA screen control and any subsequent control lots are incompatible with older lot numbers of ANA calibrators and ANA reagent packs..
- Recalling firm
- Bio-Rad Laboratories, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-11-01
- Terminated
- 2023-09-27
- Firm location
- Redmond, WA, United States
510(k) clearances named in this recall
2 on FDA's record- K113610 — ANA-SCREEN WITH MDSS
- K041658 — BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent Packs/ANA Kits, REF: 665-1150; and ANA Screen Calibrator Sets, REF: 663-1101
Reason for recall
A new lot of ANA screen control and any subsequent control lots are incompatible with older lot numbers of ANA calibrators and ANA reagent packs.
Data sourced from openFDA. This site is unofficial and independent of the FDA.