FDA Medical Device Recalls (openFDA)
Quest International, Inc.: SeraQuest***CMV IgM TEST SET For the detection of CMV IgM Antibodies 96 Test Set Cat. No. 01-150 Store 2-8 C For In Vitro Diagnostic Use***Contents: 1 96 wells bag with holder, 1 Negative Control*, 1 Positive Control*, 1 Substrate, 1 Stop Solution, 1 Conjugate*, 1 Calibrator 1*, 1 Calibrator 2*, 1 Diluent for Specimen*, 1 Wash Concentrate*, *Contains Sodium Azide Lot No. E1700 Doral, FL 33122 USA Exp. Date: May 11. BIORAD***CMV IgM EIA For the detection of CMV IgM Antibodies Xn-HARMFUL Cat. No. 25178 96 Test Set Store 2-8 C ID: grey For In Vitro Diagnostic Use*** Contents: I CMV IgM Microplate (96 wells), 1 Negative Control* (0.6 mL), 1 Positive Control (0.6 mL), 1 Substrate (12 mL), 1 Stop Reagent (12 mL), 2 Conjugate* (12 mL), 1 Calibrator 1* (0.6 mL), 1 Calibrator 2* (0.6 mL) , 1 Diluent* (25 mL), 1 Wash Concentrate* (30 mL), *0.1% Sodium Azide Lot No. E1700 Distributed by: Bio-Rad Laboratories-Redmond, WA 98052.
- Recall number
- Z-0837-2012
- Recalling firm
- Quest International, Inc.
- Product
- SeraQuest***CMV IgM TEST SET For the detection of CMV IgM Antibodies 96 Test Set Cat. No. 01-150 Store 2-8 C For In Vitro Diagnostic Use***Contents: 1 96 wells bag with holder, 1 Negative Control*, 1 Positive Control*, 1 Substrate, 1 Stop Solution, 1 Conjugate*, 1 Calibrator 1*, 1 Calibrator 2*, 1 Diluent for Specimen*, 1 Wash Concentrate*, *Contains Sodium Azide Lot No. E1700 Doral, FL 33122 USA Exp. Date: May 11. BIORAD***CMV IgM EIA For the detection of CMV IgM Antibodies Xn-HARMFUL Cat. No. 25178 96 Test Set Store 2-8 C ID: grey For In Vitro Diagnostic Use*** Contents: I CMV IgM Microplate (96 wells), 1 Negative Control* (0.6 mL), 1 Positive Control (0.6 mL), 1 Substrate (12 mL), 1 Stop Reagent (12 mL), 2 Conjugate* (12 mL), 1 Calibrator 1* (0.6 mL), 1 Calibrator 2* (0.6 mL) , 1 Diluent* (25 mL), 1 Wash Concentrate* (30 mL), *0.1% Sodium Azide Lot No. E1700 Distributed by: Bio-Rad Laboratories-Redmond, WA 98052.
- Status
- Terminated
- Initiated
- 2010-09-28
- Posted
- 2012-01-23
- Terminated
- 2012-05-31
- Reason
- Quest International recalled their CMV IgM Test kit because the device failed the test run due to lack of activity in the coated wells.
- Root cause
- Storage
- Action
- On September 28, 2010, Quest International, Inc. issued a Memo to its Customers who received the CMV IgM Lot E1700. The memo identified the affected product and stated the problem with the device. The memo asked customers to let the firm know if they had any remaining inventory from the affected lot and the product would be replaced immediately. Questions should be directed to 305-592-6991.
- Quantity
- 315
- Distribution
- Nationwide Distribution -- Washington and California.
- Lot, serial or model codes
- Lot Number: E1700
- 510(k) numbers
- ["K982485"]
- PMA numbers
- not on file
- Product code
- LKQ
- Firm FEI
- 3000206132
- Firm city
- Doral
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28