CLASS III Device recall · Reported 4 Jan 2017 · FDA Enforcement Report
Hdl Cholesterol (Pef Method) for IN Vitro Diagnostic Use recalled
Sterling Diagnostics is recalling Sterling Diagnostics, Inc., Hdl Cholesterol (Pef Method) for IN Vitro Diagnostic Use in, distributed in Michigan, Virginia. The recall was initiated on 20 Jul 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-0930-2017
- FDA event ID
- 75591
- Recalling firm
- Sterling Diagnostics, Sterling Heights, MI
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 20 Jul 2016
- FDA classified
- 29 Dec 2016
- Reported
- 4 Jan 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 20 Jul 2016 | Recall initiated by company | |
| 29 Dec 2016 | Classified by FDA | +162 days |
| 4 Jan 2017 | 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
Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.
Product as listed by the FDA
Sterling Diagnostics, Inc., HDL Cholesterol (PEF Method) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
Where it was distributed
Domestic: MI Foreign: Phillipines VA/DOD: None
Questions about this recall
Is Hdl Cholesterol (Pef Method) for IN Vitro Diagnostic Use in the quantitative recalled?
Yes. Sterling Diagnostics recalled Hdl Cholesterol (Pef Method) for IN Vitro Diagnostic Use in the quantitative on 20 Jul 2016. The recall is Class III and its status is Terminated. Recall number Z-0930-2017.
Why was it recalled?
Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.
Which lots are affected?
HDL Cholesterol, CAT No. 2150-P, Lot No. 15051, Expriry: 3/18, Manufactured: 03/10/15
Where was it sold?
Domestic: MI Foreign: Phillipines VA/DOD: None
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 Sterling Diagnostics
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|---|---|---|---|---|---|
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