Ortho-Clinical Diagnostics FDA Inspection Record
Ortho-Clinical Diagnostics is an FDA-registered facility (FEI 3007111389) located in Pencoed Bridgend, GB. RegDataLab tracks 5 FDA inspections at this facility.
What FDA found at this site
- Latest inspection
- Feb 1, 2018: No Action Indicated (NAI)
- Inspections on record
- 5 (5 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 11, latest Jun 5, 2023
- Import refusals
- 1
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Feb 1, 2018 | No Action Indicated (NAI) | No citations listed |
| May 1, 2014 | No Action Indicated (NAI) | No citations listed |
| May 6, 2011 | No Action Indicated (NAI) | No citations listed |
| May 12, 2010 | No Action Indicated (NAI) | No citations listed |
| Oct 12, 2009 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Jun 5, 2023 | Class II | Z-2357-2023 | VITROS Immunodiagnostic Products Troponin I ES Reagent Pack and 1 more product Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results. |
| Nov 1, 2018 | Class II | Z-0687-2019 | VITROS Anti-HBe Reagent Pack, Cat No. 6801816
Product Usage:
For the in vitro… and 2 more products The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional… |
| Mar 7, 2017 | Class II | Z-1765-2017 | VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD… Increased frequency of calibration failures for VITROS Immunodiagnostic Products NT-proBNP Reagent Lots 1568, 1570, 1580 and 1590, due to… |
| Oct 5, 2016 | Class II | Z-0903-2017 | VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN 10758750006287 / Product… The device defect is a positive bias of up to 20% relative to the currently marketed Roche device. In addition, the firm states that during… |
| Jul 28, 2016 | Class III | Z-2580-2016 | VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191… A field correction was issued by the firm for VITROS TSH reagent lot 5040 due to a higher than expected frequency of customer calibration… |
| Jul 14, 2016 | Class II | Z-2352-2016 | VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identifier No… Ortho Clinical Diagnostics has issued a recall of their VITROS immunodiagnostics Estradiol Reagent assay. The firm was made aware of a… |
| Jun 2, 2016 | Class II | Z-2302-2016 | VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code 874 4468, Unique… Ortho-Clinical Diagnostics confirmed that sample results generated from VITROS Immunodiagnostic Products Total T4 Reagent Packs may show a… |
| May 9, 2016 | Class III | Z-2145-2016 | VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique… Ortho Clinical Diagnostics (OCD) confirmed that specific lots of VITROS Immunodiagnostic Products AFP Reagent Pack product exhibit an… |
| May 6, 2015 | Class III | Z-1707-2015 | VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device… The Immunodiagnostic Products Signal Reagent, Lot 3082 as the reagent packs may contain blank labels. |
| Aug 6, 2014 | Class II | Z-2671-2014 | VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection… VITROS Immunodiagnostic Products Anti-HCV kit lot 9090 has been observed producing sporadic lower than expected VITROS Anti-HCV test results… |
FDA record score
4 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.
8 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Class II recall Z-2357-2023, this FEI as the recalling firm | Jun 5, 2023 | 4 x 0.6 | 2.4 |
| Class II recall Z-0687-2019, this FEI as the recalling firm | Nov 1, 2018 | 4 x 0.25 | 1 |
| Class II recall Z-1765-2017, this FEI as the recalling firm | Mar 7, 2017 | 4 x 0.25 | 1 |
| Class II recall Z-0903-2017, this FEI as the recalling firm | Oct 5, 2016 | 10 years or older, so it adds no points | 0 |
| Class II recall Z-2352-2016, this FEI as the recalling firm | Jul 14, 2016 | 10 years or older, so it adds no points | 0 |
| Class II recall Z-2302-2016, this FEI as the recalling firm | Jun 2, 2016 | 10 years or older, so it adds no points | 0 |
| Class II recall Z-2671-2014, this FEI as the recalling firm | Aug 6, 2014 | 10 years or older, so it adds no points | 0 |
| Class II recall Z-2183-2014, this FEI as the recalling firm | Jul 16, 2014 | 10 years or older, so it adds no points | 0 |
When each source was last refreshed
| Records | Last refreshed | Source as of | Status |
|---|---|---|---|
| Inspections | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions (warning letters, injunctions and other action types) | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
| Warning letter text | Nov 14, 2026 | Newest record Nov 10, 2026 | Current |
| Recalls (Enforcement Report) | Nov 14, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 2, 2026 | Newest record Oct 22, 2026 | Current |
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Facility details
- Company
- ORTHO-CLINICAL DIAGNOSTICS
- Location
- Pencoed Bridgend (GB)
- Source
- device