Z-1911-2016Class II

Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T The...

Name: Z-1911-2016 Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T The...
Creator: Integrated Science Systems Inc
Published: 2016-02-19
License: https://open.fda.gov/license/

Integrated Science Systems Inc / initiated 2016-02-19 / Terminated / root cause: manufacturing process

FDA source

Integrated Science Systems Inc began a recall of Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T The product is used as an aid in the identification of... on 2016-02-19. FDA classified it as Class II and gives the reason as "Customer complaints of very weak reactions with the kit, or false negative results with different Staph aureus cultures". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1911-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-19
Posted: 2016-06-03
Terminated: 2017-02-28
Recalling firm: Integrated Science Systems Inc
Product: Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T The product is used as an aid in the identification of Staphylococcus aureus from Culture
Product code: LHJ Staphylococcus Aureus Protein A Insoluble
Reason for recall: Customer complaints of very weak reactions with the kit, or false negative results with different Staph aureus cultures.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Integrated Science Systems sent a Recall Notification letter dated March 29, 2016. Integrated Science Systems requested that unopened kits in inventory be returned. Once the root cause has been determined, the kits will be reworked and returned to INOVA for distribution. For questions call 706-922-8686.
Quantity in commerce: 2625 kits
Distribution: Nationwide distribution to CA only.
Product codes and lots: Lot Numbers - KJ05016, KJ05017, KJ05018, KJ06019, KJ06020, KJ06021, KJ07023, KJ10028, J06022, KJ07024, KJ07025, KJ09026, KJ09027, KJ10029, KJ10030, KJ11034, KJ11035, KJ12040, KJ12041, KJ12042, KJ12043

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1911-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1911-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-03

Product code LHJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)