Recall Z-0441-2021— Hardy Diagnostics
Class III · Terminated
Class III FDA medical device recall by Hardy Diagnostics, initiated 2020-10-06, terminated 2021-05-28. It names one FDA 510(k) clearance: K170586. Product: Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499. Reason: Streptococcus culture medium contains an incorrect expiration date. The culture medium outer box labeling contains an expiration date of 2021-11-10 instead of the correct expiration date of 2020-11-10.
- Recalling firm
- Hardy Diagnostics
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2020-10-06
- Terminated
- 2021-05-28
- Firm location
- Santa Maria, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499
Reason for recall
Streptococcus culture medium contains an incorrect expiration date. The culture medium outer box labeling contains an expiration date of 2021-11-10 instead of the correct expiration date of 2020-11-10
Data sourced from openFDA. This site is unofficial and independent of the FDA.