CLASS III Device recall · Reported 2 Sep 2020 · FDA Enforcement Report

Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate recalled

OraSure Technologies is recalling Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral, distributed nationwide in the US. The recall was initiated on 13 Jul 2020 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot Number: 6673116 Exp. Date:03/31/2020

Quantity recalled13 kits

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-2877-2020
FDA event ID: 86122
Recalling firm: OraSure Technologies, Bethlehem, PA
Classification: Class III
Status: Terminated
Recall initiated: 13 Jul 2020
FDA classified: 24 Aug 2020
Reported: 2 Sep 2020
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Potency & Assay
Device type: Test Kits & Diagnostics

Timeline

13 Jul 2020	Recall initiated by company
24 Aug 2020	Classified by FDA	+42 days
2 Sep 2020	Published in enforcement report	+9 days

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

Reason for recall

Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for Benzodiazepines, Product Number: 1110IT

Where it was distributed

Worldwide distribution - US Nationwide distribution including in the states of DC, FL, PA, MD, NM, NY, NV, PA and the country of France.

Nationwide District of Columbia Florida Maryland New Mexico Nevada New York Pennsylvania

Questions about this recall

Is Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated recalled?

Yes. OraSure Technologies recalled Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated on 13 Jul 2020. The recall is Class III and its status is Terminated. Recall number Z-2877-2020.

Why was it recalled?

Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box

Which lots are affected?

Lot Number: 6673116 Exp. Date:03/31/2020

Where was it sold?

Worldwide distribution - US Nationwide distribution including in the states of DC, FL, PA, MD, NM, NY, NV, PA and the country of France.

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from OraSure Technologies

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