Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) Product is intended for use by clinical laborat
FDA device recall Z-0722-2017 · posted 2016-12-08 · Terminated
Recall details
- Recalling firm
- OraSure Technologies, Inc.
- Reason for recall
- Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due to incorrect selection of Microplate during manufacturing.
- Action taken
- 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
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- DIS
- Quantity affected
- 4 kits
- Distribution
- Distributed to KS, and VA
- Date initiated
- 2016-11-10
- Date posted
- 2016-12-08
- Date terminated
- 2017-04-17
- Location
- Bethlehem, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I (K001976) | OraSure Technologies, Inc. | 2000-12-06 |