510(k) · Cleared
Recalled · Class II · 2022Vitros Immunodiagnostic Products Prolactin Reagent Pack/Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Clinical Diagnostics, Inc. · CFT Radioimmunoassay, Prolactin (Lactogen)
Cleared on Feb 25, 1997 after a 32-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has been recalled 2 times.
- Decided
- Feb 25, 1997
- Review
- 32 days
- Class
- Class I
- Product code
- CFT
- Recalls
- 2
- Predicates
- 0
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CFT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 25, 2022 | Class II | Z-1114-2022 | Device Design | Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. Low-level quality control (QC) and patient samples at the low end of the… |
| Jul 12, 2018 | Class II | Z-0060-2019 | Device Design | The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions For Use (IFU). Patients who… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All CFT devicesCFT Radioimmunoassay, Prolactin (Lactogen): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CFT
FDA has decided no CFT device since 2007.
Median 510(k) review, days · CFT
Too few CFT 510(k)s in any year since 2007 to give a median.
Recalls per year · CFT
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CFT
23in 2025
MAUDE reports naming product code CFT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 2 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 18 |
| 2018 | 0 | — | 1 | 27 |
| 2019 | 0 | — | 0 | 12 |
| 2020 | 0 | — | 0 | 20 |
| 2021 | 0 | — | 0 | 23 |
| 2022 | 0 | — | 0 | 29 |
| 2023 | 0 | — | 0 | 27 |
| 2024 | 0 | — | 0 | 25 |
| 2025 | 0 | — | 0 | 23 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K970281 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970281: Vitros Immunodiagnostic Products Prolactin Reagent Pack/Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970281
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026