Z-0722-2017Class III

Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) Product is intended for use by...

Name: Z-0722-2017 Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) Product is intended for use by...
Creator: OraSure Technologies, Inc.
Published: 2016-11-10
License: https://open.fda.gov/license/

OraSure Technologies, Inc. / initiated 2016-11-10 / Terminated / root cause: manufacturing process

FDA source

OraSure Technologies, Inc. began a recall of Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) Product is intended for use by clinical laboratories in the qualitative determination... on 2016-11-10. FDA classified it as Class III and gives the reason as "Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due to incorrect selection of Microplate during manufacturing". 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-0722-2017
Classification: Class III
Status: Terminated
Initiated: 2016-11-10
Posted: 2016-12-08
Terminated: 2017-04-17
Recalling firm: OraSure Technologies, Inc.
Product: Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) Product is intended for use by clinical laboratories in the qualitative determination of barbiturates in oral fluids.
Product code: DIS Enzyme Immunoassay, Barbiturate
Reason for recall: Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due to incorrect selection of Microplate during manufacturing.
Root cause tag: manufacturing process
FDA root cause: Mixed-up of materials/components
Action: Due to the small number of customers that were affected by the recall, OraSure notified customers on November 10, 2016, via telephone with a follow-up email. Customers were asked to quarantine the units on hand and they will schedule a pickup by Fed EX to retrieve the affected units. For further questions, please call (610) 882-1820, ext. 1657
Quantity in commerce: 4 kits
Distribution: Distributed to KS, and VA
Product codes and lots: Lot # 6654085

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0722-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0722-2017	Class III	Terminated	Voluntary: Firm initiated	2016-12-14	2016-12-08

Product code DIS

K001976Class IIStc Barbiturates Intercept Micro-Plate Eia, Model 1108IOraSure Technologies, Inc. / cleared 2000-12-06

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)