FDA Medical Device Recalls (openFDA)
Gen-Probe Inc: Gen-Probe AccuProbe Group B Streptococcus Culture Identification Test Kit, 2820.
- Recall number
- Z-1436-2011
- Recalling firm
- Gen-Probe Inc
- Product
- Gen-Probe AccuProbe Group B Streptococcus Culture Identification Test Kit, 2820.
- Status
- Terminated
- Initiated
- 2008-12-30
- Posted
- 2011-03-10
- Terminated
- 2011-06-08
- Reason
- This recall has been initiated following the identification of certain assay tubes that do not contain probe reagent. The affected kits may contain a combination of tubes with correct probe amount, partial probe amount and some probe tubes that are empty. Possible false negative results.
- Root cause
- Process control
- Action
- Gen-Probe issued a Recall Notice to customers recommending that they discontinue the use of the identified batch (lot) numbers listed. For customers that have used these batches and obtained negative results, they recommend that the referring physician be notified about the possibility of a false negative result. With the Recall Notice, consignees received a Customer Response Form to complete. Gen-Probe requested that they segregate the affected batches listed on the Customer Response Form, then reconcile, and destroy all partial and/or full kits left in inventory, being sure to document the amount destroyed on the Customer Response Form. Gen-Probe should be updated via phone, fax, and email information. Customers should then sign and return the completed form to Gen-Probe via fax to 858-410-8250, or scanned and emailed to technicalsupport@genprobe.com. The Technical Support team should be contacted for replacement kits. Technical Support was also available for additional information at 888-484-4747 or technicalsupport@gen-probe.com.
- Quantity
- 1055 kits
- Distribution
- Worldwide Distribution -- USA, including Puerto Rico and countries of Australia, Guatemala, Malaysia, Bahamas, Hong Kong, Mali, Singapore, Bermuda, India, Mexico, South Africa, Canada, Israel, Netherlands, South Korea, Finland, Kuwait, Panama, Thailand, France, Latvia, and Philippines.
- Lot, serial or model codes
- Lots (batches): 554077, 551345, 556007, 556185, 555368, 554864, 556421, 555167, 555096, 555166, 556184, and 554524 (Internationally): 554076, 555622
- 510(k) numbers
- ["K974572"]
- PMA numbers
- not on file
- Product code
- MDK
- Firm FEI
- 2024800
- Firm city
- San Diego
- Firm state
- CA
- 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