Recall Z-3220-2011
Becton Dickinson & Co. · initiated May 24, 2011
Product
BD MAX GBS Catalog Number 441772 For In Vitro Diagnostic Use, For use with the BD MAX system.The Sample Preparation Reagent kit consists of 24 (2 x 12) 2D barcode tubes which verifies against the number entered in the worklist with the handheld barcode reader. The BD MAX System is a qualitative in vitro diagnostic test obtained from vaginal and rectal swab specimens from antepartum pregnant women designed to detect Group B Streptococcus (GBS) DNA in Lim Broth cultures after incubation for greater than or equal to 18 hours. The BD MAX DNA extraction kit is used with the BD MAX System to extract DNA from Gram-negative bacteria and viruses, which may be present in clinical specimens.
Codes / lots: Lot numbers 103271, 103272, 110071, 110072, 110391, 110401, 110521, 110522, 110561, 110562, 110181, 110611, 110941, 110942, 111111
Reason for recall
Medical device bar code reader does not function as intended and could result in associating clinical test results to wrong patient.
FDA-determined cause: Nonconforming Material/Component
Action taken
BD Diagnostic Systems sent an "URGENT PRODUCT RECALL" letter dated May 2011, to all affected customers. The letter identified the products, the problem, and the action to be taken by the customers. The letter advised customers to discontinue use of the Sample Preparation Reagent tubes in the referenced kits and discard any remaining products. Customers were requested to complete an attached reply form to acknowledge their receipt of the notification and fax it to (410) 316-4258. For further assistance regarding replacements contact BD Customer Service Dept. 1-800-675-0908. For all other inquiries, contact BD Technical Services Dept. 1-800-638-8663.
Details
- Recall number
- Z-3220-2011
- Initiated
- May 24, 2011
- Posted by FDA
- September 16, 2011
- Terminated
- October 12, 2011
- Product code
- NQX – System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
- Quantity
- 61 kits
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of CA, KY, MD, MI, NC, NY, TX, and WI and the country Belgium.
- Recalling firm
- Becton Dickinson & Co., Sparks, MD
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3216-2011 | BD MAX DNA Extraction Kit DNA-1 (Urine/Plasma) Catalog Number 437501. Kit contains 24/2D…Sample results maybe switched between time it was scanned with handheld barcode reader and time it was… | 05/24/2011Terminated |
| Z-3217-2011 | BD MAX DNA Extraction Kit DNA-2 (Whole Blood) Catalog Number 437502. Kit contains 24/2D…Sample results maybe switched between time it was scanned with handheld barcode reader and time it was… | 05/24/2011Terminated |
| Z-3218-2011 | BD MAX DNA Extraction Kit DNA-3 (Swabs in Transport Medium/UTM), Catalog Number 437503.…Sample results maybe switched between time it was scanned with handheld barcode reader and time it was… | 05/24/2011Terminated |
| Z-3219-2011 | BD MAX RNA Extraction Kit RNA-3, Catalog Number 437506. Kit contains 24/2D barcode…Sample results maybe switched between time it was scanned with handheld barcode reader and time it was… | 05/24/2011Terminated |