CLASS III Device recall · Reported 2 Apr 2014 · FDA Enforcement Report
Single Analyte DAU Calibrator Norbuprenorphine: Cutoff Calibrator recalled
Lin-Zhi International is recalling Single Analyte DAU Calibrator Norbuprenorphine: Cutoff Calibrator, distributed in California. The recall was initiated on 18 Feb 2014 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-1270-2014
- FDA event ID
- 67607
- Recalling firm
- Lin-Zhi International, Sunnyvale, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 18 Feb 2014
- FDA classified
- 21 Mar 2014
- Reported
- 2 Apr 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 18 Feb 2014 | Recall initiated by company | |
| 21 Mar 2014 | Classified by FDA | +31 days |
| 2 Apr 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Customer reported that the Synchron NBUP cutoff calibrator (10 ng/mL) could not be qualified through quality control testing. The cutoff calibrator was recovering at a concentration close to the NBUP Control Level 1 (7 ng/mL).
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
Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; IVD - for in vitro diagnostic use only; Lin-Zhi International Sunnyvale, CA The Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator is used for qualitative and semi-qualitative calibration of the Lin-Zhi Internal, Inc. Buprenorphine (BUP) enzyme Immunoassay (REF # A53684) on the Synchron Clinical Analyzer
Where it was distributed
US Distribution including CA.
Questions about this recall
Is Single Analyte DAU Calibrator Norbuprenorphine: Cutoff Calibrator recalled?
Yes. Lin-Zhi International recalled Single Analyte DAU Calibrator Norbuprenorphine: Cutoff Calibrator on 18 Feb 2014. The recall is Class III and its status is Terminated. Recall number Z-1270-2014.
Why was it recalled?
Customer reported that the Synchron NBUP cutoff calibrator (10 ng/mL) could not be qualified through quality control testing. The cutoff calibrator was recovering at a concentration close to the NBUP Control Level 1 (7 ng/mL).
Which lots are affected?
Product catalog number: A68827; Lots 1308006, 1308131, Expiry: March 28, 2015.
Where was it sold?
US Distribution including CA.
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 Lin-Zhi International
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Ethyl Alcohol Enzymatic Assay, (a) recalled by Lin-Zhi International | Lin-Zhi International | Potency & Assay | Nationwide |
| Device | CLASS II | Cannabinoids DAU Calibrator Control Level 1 5 ng/mL) This recalled | Lin-Zhi International | Sterility | Nationwide |
| Device | CLASS II | Cannabinoids DAU Calibrator Control Level 1 5 ng/mL) This recalled | Lin-Zhi International | Sterility | Nationwide |
| Device | CLASS III | Single Analyte Urine DAU Control (5 m L Norbuprenorphine recalled | Lin-Zhi International | Potency & Assay | CA |
Other Test Kits & Diagnostics recalls
All 2,656| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | STA Staclot Protein S recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |