FDA Medical Device Recalls (openFDA)
Biochemical Diagnostics Inc: CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Controls are intended to validate the performance of qualitative hCG urine procedures and immunochromatographic devices.
- Recall number
- Z-0328-2016
- Recalling firm
- Biochemical Diagnostics Inc
- Product
- CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Controls are intended to validate the performance of qualitative hCG urine procedures and immunochromatographic devices.
- Status
- Terminated
- Initiated
- 2015-09-14
- Posted
- 2015-11-23
- Terminated
- 2016-01-26
- Reason
- CONSULT diagnostics hCG Controls have discrepant storage temperatures listed on the kit labels when compared with the individual vial labels and the package insert.
- Root cause
- Labeling False and Misleading
- Action
- Biochemical Diagnostics sent a Notice of Correction Letter (dated August 26, 2015) to customers via USPS 1st class mail. The letter identified the affected product, problem and actions to be taken. Customers were instructed to return the verification form, per the notification. For questions contact Alere Technical Service at 866-216-0094 or by email at verifications.at verifications.ts@alere.com.
- Quantity
- Domestic: 4,473 kits
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- Lot/Codes: KN165 (exp. 2017-09), KN169 (exp. 2017-10), KN171 (exp. 2017-11) and KN177 (exp. 2018-02)
- 510(k) numbers
- ["K050328"]
- PMA numbers
- not on file
- Product code
- JJX
- Firm FEI
- 2432495
- Firm city
- Edgewood
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28