FDA Medical Device Recalls (openFDA)
Hardy Diagnostics: Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.
- Recall number
- Z-1571-2016
- Recalling firm
- Hardy Diagnostics
- Product
- Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.
- Status
- Terminated
- Initiated
- 2016-03-21
- Posted
- not on file
- Terminated
- 2016-10-25
- Reason
- Performance failure; poor hemolytic reaction of non or weakly hemolytic group B streptococcus (GBS) with the target QC organism, Streptococcus agalactiae (ATCC 13813) due to product deterioration.
- Root cause
- Under Investigation by firm
- Action
- On 03/21/2016 customers were notified by phone, and were sent a notification letter. Customers were instructed via phone call to discard remaining plates of the implicated lot, and to notify the firm of how many plates are left. The firm stated that they will be issuing replacements. The firm stated that they will be sending written notification as well. The firm requested full name and e-mail or fax number in order to follow-up with the written notification. The customer notification letter instructs customers to complete, sign, scan/e-mail or fax back enclosed form stating compliance with the action regarding the specific lot. The firm requests the form be returned to the attention of the Quality Assurance Department at techservice@hardydiagnostics.com, fax number 805-614-9274. If the lab is unable to be reached via telephone and would like replacements or credit contact Customer Service Department at 800-266-2222, option 1. Replacements will be sent out at no charge. Any questions contact Technical Services Department at 800-266-2222, option 2 or via e-mail at techservice@hardydiagnostics.com.
- Quantity
- 3,530 (353 pk/10)
- Distribution
- U.S. Distribution to the following states: AL, SC, FL, CT, VA, WI, MA, MI, WV, OH, IN, IL, NC, and TX.
- Lot, serial or model codes
- Lot H16054 and H15056.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JSJ
- Firm FEI
- 2022807
- Firm city
- Santa Maria
- 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