CLASS II Device recall · Reported 4 May 2016 · FDA Enforcement Report

GBS Detect recalled by Hardy Diagnostics

Hardy Diagnostics is recalling GBS Detect, distributed in 14 states. The recall was initiated on 21 Mar 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot H16054 and H15056.

Quantity recalled3,530 (353 pk/10)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1571-2016
FDA event ID: 73688
Recalling firm: Hardy Diagnostics, Santa Maria, CA
Classification: Class II
Status: Terminated
Recall initiated: 21 Mar 2016
FDA classified: 26 Apr 2016
Reported: 4 May 2016
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Device Malfunction
Device type: Test Kits & Diagnostics

Timeline

21 Mar 2016	Recall initiated by company
26 Apr 2016	Classified by FDA	+36 days
4 May 2016	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.

Where it was distributed

U.S. Distribution to the following states: AL, SC, FL, CT, VA, WI, MA, MI, WV, OH, IN, IL, NC, and TX.

Alabama Connecticut Florida Illinois Indiana Massachusetts Michigan North Carolina Ohio South Carolina Texas Virginia Wisconsin West Virginia

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

Lot H16054 and H15056.

Where was it sold?

U.S. Distribution to the following states: AL, SC, FL, CT, VA, WI, MA, MI, WV, OH, IN, IL, NC, and TX.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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