Terminated

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

FDA Recall Z-0082-2022 · Posted None

Recalling FirmBio-Rad Laboratories, Inc.

Recall StatusTerminated

Product CodeLKJ

Date Initiated2019-11-01

Date Terminated2023-09-27

Product Quantity206

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.

Firm Action

On 11/01/2019, ANA Screen Lot Matching-Compatibility Notice, were mailed to customers. Customers were advised of the following: If you have received the new control material, please ensure that your laboratory is using one of the newer lot numbers of BioPlex ANA calibrators and ANA reagents. Should you have any of the older BioPlex ANA reagent packs and calibrator sets listed below in ITALICS remaining in your inventory or if you have used these lots in combination with the new control, please contact your local Technical Support center. The following telephone number was provided: 510-724-7000.

Root Cause

Process control

Distribution Pattern

Worldwide distribution - U.S Nationwide distribution including in the states of CA, FL, NJ, IL, NE, TN, IN, TX, LA, WA, MI, MA, MN, OH, HI, MO, PA, CT, UT, SD, NY, AL, PR, OR, MD, KY, NC, AZ, SC, VA, WI, GA, IA, RI, AK, OK, KS, ND, MS, ME, NM, AR and the countries of ES, AE, DE, FR, KR, CN, TW, JP, IL, SG, AU, NZ, HK, IT, CA, PT, GB, NO, CZ, SE, CH, UA, RU, BE, DK.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K113610ANA-SCREEN WITH MDSSBio-Rad Laboratories · 2012-07-09 K041658BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200Bio-Rad Laboratories, Inc. · 2004-12-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.