CLASS III Device recall · Reported 14 Dec 2016 · FDA Enforcement Report
Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay recalled
OraSure Technologies is recalling Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) Product is, distributed in Kansas, Virginia. The recall was initiated on 10 Nov 2016 and the FDA has classified it as Class III.
Check your package
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-0722-2017
- FDA event ID
- 75681
- Recalling firm
- OraSure Technologies, Bethlehem, PA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 10 Nov 2016
- FDA classified
- 8 Dec 2016
- Reported
- 14 Dec 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 10 Nov 2016 | Recall initiated by company | |
| 8 Dec 2016 | Classified by FDA | +28 days |
| 14 Dec 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due to incorrect selection of Microplate during manufacturing.
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
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.
Where it was distributed
Distributed to KS, and VA
Questions about this recall
Is Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) Product is recalled?
Yes. OraSure Technologies recalled Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) Product is on 10 Nov 2016. The recall is Class III and its status is Terminated. Recall number Z-0722-2017.
Why was it recalled?
Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due to incorrect selection of Microplate during manufacturing.
Which lots are affected?
Lot # 6654085
Where was it sold?
Distributed to KS, and VA
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.
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