Z-1797-2018Class II

MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP)...

Name: Z-1797-2018 MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP)...
Creator: Diagnostic Hybrids, Inc.
Published: 2016-07-14
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2016-07-14 / Terminated / root cause: manufacturing process

FDA source

Diagnostic Hybrids, Inc. began a recall of MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum on 2016-07-14. FDA classified it as Class II and gives the reason as "There is a possibility of low volume and/or leaking standard bottles". 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-1797-2018
Classification: Class II
Status: Terminated
Initiated: 2016-07-14
Posted: 2018-05-10
Terminated: 2020-08-28
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum.
Product code: CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Reason for recall: There is a possibility of low volume and/or leaking standard bottles.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Customers were contacted via telephone and a letter dated 7/14/16. The letter instructed customers to review their inventory for the specified lot number, check for any low-volume or leaking standards, and contact the recalling firm if necessary.
Quantity in commerce: 1004
Distribution: The products were distributed to the following US states: CA, CT, GA, IL, KY, MA, MD, MO, PA, TX, WA, and WI. The products were distributed to the following foreign countries: Australia, Brazil, Canada, China, Costa Rica, India, Japan, Mexico, The Philippines, Russia, South Korea, South Africa, Switzerland, and Uruguay.
Product codes and lots: Lot 067850

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1797-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1797-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-10

Product code CIN

K981373Class IIAlkphase-B Assay KitMetra Biosystems, Inc. / cleared 1998-05-27

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)