Quest EIA ANA Screen Bulk Kit, model number 96AN-BPU-QUEST. Manufactured by Bio-Rad Laboratories, Inc., Hercules, CA. Fo

FDA device recall Z-0608-2011 · posted 2010-12-13 · Terminated

Recall details

Recalling firm

Bio-Rad Laboratories Inc

Reason for recall

The value for the ANA Cutoff and ANA Positive Controls will decrease overtime resulting in an unusually elevated positivity rate for patient samples tested.

Action taken

Bio-Rad Laboratories, Inc. sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter dated February 24, 2010, to their customer. The letter identified the product, the problem, and the action to be taken. The customer was instructed to: Examine inventory and quarantine affected product. Identify all customers that have received the affected product and immediately notify them. Instruct them to discontinue use of the affected product. Complete and return the enclosed MEDICAL DEVICE RECALL RESPONSE FORM. For questions regarding this recall call (510) 724-7000.

Root cause

Other

Status

Terminated

Product code

LKJ

Quantity affected

453 kits

Distribution

Nationwide Distribution including FL

Date initiated

2010-02-26

Date posted

2010-12-13

Date terminated

2011-01-05

Location

Hercules, CA