Siemens Healthcare recalls Syva EMIT 2000 Theophylline Assay lot J1 due to potential increased imprecision when used with Beckman AU Clinical Chemistry System. Affected units may show inaccurate results for controls and patient samples.
Lot J1 of the Syva¿ EMIT¿ 2000 Theophylline Assay, when run on a Beckman AU Clinical Chemistry System, may exhibit increased imprecision for commercially available controls and for patient samples.
Siemens Healthcare is recalling a specific lot of the Syva EMIT 2000 Theophylline Assay because it may produce inaccurate results when used with certain clinical chemistry systems. This could lead to incorrect theophylline measurements in patient samples, which might affect treatment decisions.
The recalled lot (J1) of the Syva EMIT 2000 Theophylline Assay may show increased imprecision when run on Beckman AU Clinical Chemistry Systems. This means results for both patient samples and commercial controls could be less accurate, potentially affecting theophylline dosage decisions.
Healthcare professionals using the Syva EMIT 2000 Theophylline Assay with Beckman AU Clinical Chemistry System. Patients receiving theophylline treatment may be at risk if inaccurate measurements lead to improper dosing.
Check for the product name 'Syva EMIT 2000 Theophylline Assay', catalog number 4P019UL, and lot number J1 (UDI# 00842768001024J120190414). The product is sold with Beckman AU Clinical Chemistry Systems.
Verify the product name, catalog number 4P019UL, and lot number J1 (UDI# 00842768001024J120190414) to confirm if the item is affected.
The recall is for potential inaccurate results, not direct patient harm. Inaccurate measurements could affect treatment decisions, but the product itself is not immediately hazardous.
Inaccurate theophylline measurements could lead to incorrect dosing, which might impact treatment effectiveness or safety, but the hazard is not immediate.
Check the product details to see if it's lot J1. If affected, contact Siemens Healthcare for guidance on next steps.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1946-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1946-2018 from Siemens Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
