Use caution Medical device recall · FDA · Published October 25, 2017

Diagnostica Stago Neoplastine Cl Plus Recalled: Prolonged Prothrombin Time Risk

Diagnostica Stago recalls Neoplastine Cl Plus reagent vials with confirmed defect causing prolonged prothrombin time (PT) readings. Affected lots expire 2018-2019. Stop using if you have these lots.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1069-2018Medical device Diagnostica Stago ›

Use caution until it’s fixed

Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).

Take action

Contact the company

Recalling firmDiagnostica Stago, Inc.5 Century Dr · Parsippany, NJ 07054-4607

✎ GovInfoNow plain-language explainer

Diagnostica Stago recalls Neoplastine Cl Plus reagent vials that may give prolonged prothrombin time (PT) readings. This defect could lead to inaccurate blood clotting tests if used in normal medical procedures. Read more at govinfonow.com/recall/72662-diagnostica-stago-neoplastine-cl-plus-recalled-prolonged-prothrombin-time-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/72662-diagnostica-stago-neoplastine-cl-plus-recalled-prolonged-prothrombin-time-risk · Updated September 14, 2026 · FDA enforcement record: FDA #Z-1069-2018

Cite this page

“Diagnostica Stago Neoplastine Cl Plus Recalled: Prolonged Prothrombin Time Risk.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/72662-diagnostica-stago-neoplastine-cl-plus-recalled-prolonged-prothrombin-time-risk. Based on FDA recall #Z-1069-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1069-2018%22&limit=1).

The FDA announced on 2017-10-25 that Diagnostica Stago, Inc. voluntarily recalled STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) due to a confirmed defect of homogeneity in some reagent vials. This Class II recall affects lots distributed nationally and has been terminated.

How to tell if you have it

Brand: Diagnostica Stago
Product: STA - Neoplastine¿ Cl Plus ¿ (ref. 00606)
Lot codes: 250041RX, 250077, 250246RU, 251492, 251308, 251626, 251730, 251772
Distribution: Nationally

The hazard

According to the FDA, the recall addresses a confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%). The product is used for manual or automated determination of the prothrombin time.

Context

GovInfoNow's records show Diagnostica Stago, Inc. has 12 other recalls on record since 2026-07-29. Other recent recalls of similar products include HemosIL SynthAFax Partial Thromboplastin Time Tests Recall (2025-11-18), Siemens Dimension Creatinine Flex Reagent Cartridge Recall (2026-03-18), and St. Jude Medical Reprocessed Catheters Recall (2025-12-22).

How to tell if you have this one

Check the lot numbers on the vial: 250041RX (exp 2018-02), 250077 (exp 2018-02), 250246RU (exp 2018-03), 251492 (exp 2018-09), 251308 (exp 2018-10), 251626 (exp 2019-01), 251730 (exp 2019-02), or 251772 (exp 2019-02).

Brand
Diagnostica Stago
Category
Medical device

FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Nationally

Recall number	Product, codes & lots	Quantity
Z-1066-2018	Neoplastine¿ Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the prothrombin time (PT).; Lot 115080 (Exp: 01-2018) Lot 251241 (Exp: 01-2018)	1636 Kits
Z-1067-2018	Neoplastine¿ Cl Plus ¿ (ref. 00375) Product Usage: Manual or automated determination of the prothrombin time (PT).; Lot 250080 (Exp: 02-2018) Lot 251762 (Exp: 02-2019) Lot 251940 (Exp: 12-2018)	—
Z-1068-2018	STA - Neoplastine¿ Cl ¿ (ref. 00605) Product Usage: Manual or automated determination of the prothrombin time (PT).; Lot 251064 (Exp: 09-2018) Lot 251725 (Exp: 02-2019)	—
Z-1069-2018	STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) Product Usage: Manual or automated determination of the prothrombin time (PT).; Lot: 250041RX (Exp: 2018-02) Lot: 250077 (Exp: 2018-02) Lot: 250246RU (Exp: 2018-03) Lot: 251492 (Exp: 2018-09) Lot: 251308 (Exp: 2018-10) Lot: 251626 (Exp: 20 19-01) Lot: 251730 (Exp: 2019-02) Lot: 251772 (Exp: 2019-02)	—

Based on the official FDA remedy

What to do — step by step

Check Lot Numbers
Identify the lot number on the vial to see if it matches the affected lots listed: 250041RX, 250077, 250246RU, 251492, 251308, 251626, 251730, or 251772.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationally” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.5 years after the firm started it.

Oct 25, 2017Firm started the recall
Mar 15, 2018FDA classified it Class II
Mar 21, 2018Published in FDA’s Enforcement Report
May 12, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/72662-diagnostica-stago-neoplastine-cl-plus-recalled-prolonged-prothrombin-time-risk">Diagnostica Stago Neoplastine Cl Plus Recalled: Prolonged Prothrombin Time Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1069-2018 (October 25, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1069-2018 to see it in context.
Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.